# China NMPA Product Recall - Mobile C-arm digital X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-oec-medical-systems-inc/98e19433-5e68-4573-9a47-b1ae2362338e/
Source feed: China

> China NMPA product recall for Mobile C-arm digital X-ray system by GE OEC Medical Systems, Inc. published January 16, 2017. Recall level: . GE OEC Medical Systems, Inc., through its distributor GE Healthcare Systems Trading Development (Sha

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE OEC Medical Systems, Inc. is recalling products including mobile C-arm digital X-ray systems.
- Company Name: GE OEC Medical Systems, Inc.
- Publication Date: 2017-01-16
- Product Name: Mobile C-arm digital X-ray system
- Recall Reason: Random failures in the workstation power cord have resulted in loss of image functionality. To date, no injuries have been reported due to this failure. Nevertheless, the failure could potentially lead to surgical interruption, requiring unforeseen medical interventions.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE OEC Medical Systems, Inc.
- Summary: GE OEC Medical Systems, Inc., through its distributor GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., issued a recall concerning several models of its mobile C-arm digital X-ray systems. This recall, reported to the National Medical Products Administration (NMPA) on December 23, 2016, and published on January 16, 2017, addresses a critical safety concern. The primary issue identified is a random power cord failure within the workstation, which can result in functional image loss during operation. While no injuries have been reported to date, this malfunction poses a significant risk, potentially leading to the termination of surgical procedures and requiring further medical intervention. Under the guidance of the NMPA, the manufacturer initiated a voluntary recall (Company Recall Number: FMI15135) for the affected products. Importantly, the company clarified that the specific batch experiencing this power cord issue was not sold in China, primarily due to differing power cord specifications in the region. Nevertheless, the NMPA has instructed local food and drug administrations across all provinces to enhance supervision and management of similar products. For any inquiries regarding these products, customers are advised to contact GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.

Company: https://www.globalkeysolutions.net/companies/ge-oec-medical-systems-inc/6ef83ead-6c29-4473-b97d-60bc22e65183/